Investing.com -- The U.S. Food and Drug Administration (FDA) today initiated a process to withdraw concentrated ingestible fluoride prescription drug products for children from the market. Unlike fluoride toothpaste or rinses, these products are consumed by infants and toddlers. The FDA has not previously approved these products. Research has indicated that ingested fluoride can change the gut microbiome, which is particularly concerning given the early development of the gut microbiome in childhood. Other research has suggested a link between fluoride and thyroid disorders, weight gain, and potentially lower IQ.
FDA Commissioner Marty Makary, M.D., M.P.H., stated that the best method to prevent cavities in children is through limiting sugar consumption and maintaining good dental hygiene, not by altering a child’s microbiome. Makary explained that the same properties that allow fluoride to kill bacteria on teeth could also destroy intestinal bacteria crucial for a child’s health. He has instructed the FDA’s Center for Drug Evaluation and Research to assess the evidence concerning the risks of systemic fluoride exposure from FDA-regulated pediatric ingestible fluoride prescription drug products. This evaluation will provide parents and the medical community with more information on this emerging issue. Makary emphasized the importance of prioritizing safety when it comes to children’s health.
The FDA has set a deadline of October 31 to complete a safety review and a public comment period, and to take the necessary steps to remove these products from the market. The U.S. Department of Health and Human Services (HHS) intends to distribute best practices for children’s dental hygiene that are feasible, effective, and do not alter gut health, in line with this evaluation.
HHS Secretary Robert F. Kennedy, Jr., expressed his support for the cessation of ingestible fluoride use, stating it was long overdue. He praised Commissioner Makary for his leadership on this critical issue, which directly protects the health and development of children. Kennedy said this decision aligns with President Trump’s Make America Healthy Again initiative, designed to ensure that children grow up in a healthy environment.
This move by the FDA is in line with actions taken by several states to halt the fluoridation of drinking water. Fluoride is not added to drinking water in most of Europe or other countries worldwide.
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